01 1Bayer AG
01 1ELTANOLONE
01 1Germany
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10703
Submission : 1994-01-31
Status : Inactive
Type : II
A Eltanolone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Eltanolone, including repackagers and relabelers. The FDA regulates Eltanolone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Eltanolone API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Eltanolone supplier is an individual or a company that provides Eltanolone active pharmaceutical ingredient (API) or Eltanolone finished formulations upon request. The Eltanolone suppliers may include Eltanolone API manufacturers, exporters, distributors and traders.
click here to find a list of Eltanolone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Eltanolone DMF (Drug Master File) is a document detailing the whole manufacturing process of Eltanolone active pharmaceutical ingredient (API) in detail. Different forms of Eltanolone DMFs exist exist since differing nations have different regulations, such as Eltanolone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Eltanolone DMF submitted to regulatory agencies in the US is known as a USDMF. Eltanolone USDMF includes data on Eltanolone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Eltanolone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Eltanolone suppliers with USDMF on PharmaCompass.
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